Biokine Therapeutics Awarded FDA Orphan Drug Designation for Mobilization of Stem Cells in Patients with Cancer
Biokine Therapeutics Ltd announced that it has received Orphan Drug designation from the FDA for BKT140, a highly selective chemokine receptor antagonist that induces mobilization of hematopoietic stem cells from bone marrow into peripheral blood for collection and subsequent transplantation in patients with hematologic cancers.
Earlier in 2012, Biokine received FDA approval to conduct a phase II clinical study for stem cell mobilization in patients with multiple nyeloma and non-Hodgkin lymphoma utilizing BKT140. Biokine had previously completed a phase I/II clinical study that indicated both the drug’s safety and efficacy and its ability to shorten the number of treatment days and subsequent apheresis procedures.
Laurence Shaw, MD, Chairman of Biokine’s board of directors, said, “In both preclinical and clinical studies BKT140 had shown that by targeting the chemokine receptor CXCR4, BKT140 also appears to have the potential to treat malignancies involving this key receptor.” ■